A customer obtained higher than expected vitros phenytoin (phyt) results from a vitros therapeutic drug monitoring performance verifier (tdm pv) quality control (qc) fluid using vitros chemistry products phyt slides on a vitros 5600 integrated system.Vitros tdm pv iii lot w7852 phyt results of 32.22, 31.34, 32.18, 32.92 and 32.00 ug/ml vs.The expected result of 26.1 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected results were attained from a qc fluid.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There have not been any allegations of patient harm as a result of this event.This report is number 2 of 5 mdr¿s for this event.Five (5) 3500a forms are being submitted for this event as 5 devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).
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